FDA applicant

Strato Medical Corp.

Beverly, MA46 decisions1983–19951 recall

FDA records 46 decisions for Strato Medical Corp. (Beverly, MA) from 1983 to 1995: 45 510(k) clearances and 1 original PMA approval. Most are in product codes LJT (Port & Catheter, Implanted, Subcutaneous…) and LJS (Catheter, Intravascular, Therapeutic…). 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Strato Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Strato Medical Corp. since 2007.

Recalls per year

1in 2010

2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Strato Medical Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Strato Medical Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Strato”

FDA records each applicant name separately; these may or may not be the same firm.

Strato/Infusaid, Inc. 11 Strato-Ray Co. 2

Strato Medical Corp.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Strato”